Dendrite International announced that Clinitrac, a Stockholm, Sweden-based developer of one of the world’s first wireless patient diaries, has selected Dendrite Clinical to provide end-user and trial site telephone support for a year-long, multi-country clinical study for one of Clinitrac’s premier pharmaceutical customers. Commencing this month, the support contract will encompass 51 investigator sites in 13 countries, with Dendrite providing assistance to patients and investigators using Clinitrac’s leading eDiary Electronic Data Capture solution.
Mikael Reimerson, senior vice president of Clinitrac AB commented, ‘The expansion of Clinitrac’s eDiary business reflects growing acceptance by pharmaceutical companies and the Food and Drug Administration in the use of eDiaries during clinical trials. Dendrite is well aware of the challenges of conducting global clinical trials and the evolving use of technology to solve these challenges. The company brings global presence, pharmaceutical expertise and clinical experience, as well as quality services that include local language accommodation and 24-hour customer service for clinics and sponsors.’
Designed to help pharmaceutical companies increase clinical trial efficiency and data validity, as well as decrease products’ time-to-market, the wireless patient diary is a palm-sized hand computer with a built-in mobile phone that requires no installation, wires, or connections. The touch-sensitive screen allows the patient to answer study questionnaires merely by tapping symbols on the screen as they are presented. As the patient answers the questions, information is time-stamped and encrypted.
After all questions have been answered, the data is immediately transferred over a mobile phone network to a central server. Via a secure website, investigators/study nurses, monitors, and other sponsor staff can proactively manage patients and enhance compliance. The Clinitrac eDiary provides easy access to data and the ability to track, in real time, the progression of the study as well as enrolled patients.